Two randomized phase III clinical trials evaluating anti-inflammatory dose doxycycline (40-mg doxycycline, USP capsules) administered once daily for treatment of rosacea - 12/08/11

Doi : 10.1016/j.jaad.2006.11.021

James Q. Del Rosso, DO ^a,^⁎ , Guy F. Webster, MD, PhD ^b, Mark Jackson, MD ^c, Marta Rendon, MD ^d, Phoebe Rich, MD ^e, Helen Torok, MD ^f, Mark Bradshaw, PhD ^g
^a From the Department of Dermatology, University of Nevada School of Medicine, and Touro University College of Osteopathic Medicine, Las Vegas
^b Jefferson Medical College, Philadelphia
^c Division of Dermatology, University of Louisville
^d University of Miami School of Medicine
^e Oregon Health Sciences University, Portland
^f Trillium Creek Dermatology & Surgery Center, Medina
^g Global Consulting Partners in Medical Biometrics, Princeton

Reprint requests: James Q. Del Rosso, DO, PMB-531, 3230 E Flamingo Rd #8, Las Vegas, NV 89121.

Las Vegas, Nevada; Philadelphia, Pennsylvania; Louisville, Kentucky; Miami, Florida; Portland, Oregon; and Medina, Ohio

Abstract

Background

Doxycycline monotherapy at antimicrobial doses has been shown to be effective for the treatment of rosacea.

Objective

To evaluate the efficacy and safety of once-daily anti-inflammatory dose doxycycline for the treatment of rosacea.

Methods

In two phase III, parallel-group, multicenter, randomized, double-blind, placebo-controlled studies (studies 301 and 302), patients received 40-mg of controlled-release doxycycline (n = 269) or placebo (n = 268) for 16 weeks. The primary efficacy end point was the mean change from baseline in facial inflammatory lesion count.

Results

The mean lesion count at baseline was approximately 20 in each study arm. At week 16, the mean change from baseline in lesion count in the active-treatment groups was –11.8 in study 301 and –9.5 in study 302 compared with –5.9 and –4.3, respectively, in the placebo groups (P < .001 for both comparisons). Anti-inflammatory dose doxycycline was well tolerated; the most common adverse events were nasopharyngitis (4.8%), diarrhea (4.4%), and headache (4.4%).

Limitations

In both studies, the reduction of inflammatory lesion counts did not plateau within the 16-week time frame in either treatment group. Rosacea is often treated for a period of months or years. The duration of the studies did not allow for assessment of safety beyond 16 weeks or whether the progressive improvement seen with active treatment would continue beyond 16 weeks. Neither study assessed the effect of treatment in patients with only erythematotelangiectatic (subtype 1) rosacea.

Conclusion

Once-daily anti-inflammatory dose doxycycline appears to be effective and safe for the treatment of rosacea.

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Abbreviations used : AE, ANOVA, CEA, CMH, IGA, ITT

Esquema

Methods

Overall design of the studies

Study populations

Randomization and blinding procedures

Study medications and treatment regimens

Clinical evaluations

Efficacy and safety evaluations

Supported by CollaGenex Pharmaceuticals, Inc.
Disclosure: Dr Del Rosso has received grant/research support/honoraria from and has been a consultant/advisor and speaker for CollaGenex Pharmaceuticals, Galderma, Intendis, Medicis, Stiefel and has been a consultant/advisor, speaker and received honoraria from Bradley, Dermik, Warner-Chilcott, Ranbaxy. Dr Webster has received grant/research Support and honoraria from and been a consultant and speaker for CollaGenex Pharmaceuticals, Dermik, Galderma. Dr Jackson has received grant/research support and/or honoraria support from and been a consultant for Abbott Laboratories, Amgen, Inc. Biogen, Centocor, Inc, Collagenex Pharmaceuticals, Connetics Corporation, Genentech, Novartis Pharmaceuticals, Roche Laboratories, 3M. Dr Rendon has received grant/research support and honoraria from and been a consultant/advisor and speaker for Dermik, Galderma and received grant/research support from CollaGenex Pharmaceuticals. Dr Rich has been a consultant for and received grant/research support and/or honoraria support from Altana, Anacor, Bailer, CollaGenex Pharmaceuticals, Dow, DUSA, Galderma, Intendis, Topical Solutions, and Xoma. Dr Torok has received grant/research support or honoraria from and been a consultant/advisor and speaker for CollaGenex Pharmaceuticals, Galderma, Intendis, Stiefel and has received honoraria from and been a consultant/advisor and speaker for Amgen, Dermik, Medicis, Novartis, Ranbaxy., and has equity/interest in Medicis. Dr Bradshaw has been a consultant for CollaGenex Pharmaceuticals.
A summary of the data found in this article has been presented at Academy ’05, July 21, 2005, Chicago, Ill; the Fall Clinical Dermatology Conference, October 21 and 22, 2005, Las Vegas; and the Coastal Dermatology Seminar, October 1, 2005, Napa, Calif. Highlights of the data were presented in poster format at the 64th Annual Meeting of the American Academy of Dermatology, March 3-7, 2006, San Francisco, Calif.